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Evaluation of the Clinical Performance of the ZIKV Detect™ 2.0 IgM Capture ELISA

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ClinicalTrials.gov Identifier: NCT03776903
Recruitment Status : Completed
First Posted : December 17, 2018
Last Update Posted : December 17, 2018
Sponsor:
Collaborators:
Fast-Track Drugs & Biologics, LLC
Biomedical Advanced Research and Development Authority
Information provided by (Responsible Party):
InBios International, Inc.

Study Description
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Brief Summary:
The purpose of this study is to evaluate the performance of the ZIKV Detect™ 2.0 IgM Capture ELISA using archived confirmed ZIKV positive and confirmed ZIKV negative human serum samples.

Condition or disease Intervention/treatment
Zika Virus Infection Other: ZIKV Detect™ 2.0 IgM Capture ELISA

Detailed Description:
The purpose of this study is to evaluate the performance of the ZIKV Detect™ 2.0 IgM Capture ELISA using archived confirmed ZIKV positive and confirmed ZIKV negative human serum samples. The FDA guidance document (ZIKA SEROLOGY DE NOVO/510(K) PRE-MARKET SUBMISSIONS - Recommended Analytical and Clinical Studies for Zika Virus IgM Assays; Dated 02Jun2017; FDA/CDRH/OIR/DMD) allows for the utilization of archival serum specimens to evaluate test performance. This study will follow this guidance. Test samples will be collected from endemic sites (both presumed positive and presumed negative samples) and from non-endemic sites (presumed negative samples). All samples will be shipped to the sponsor for randomization and will be tested at three sites in the United States.
Study Design
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Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Evaluation of the Clinical Performance of the ZIKV Detect™ 2.0 IgM Capture ELISA
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Zika Virus

Groups and Cohorts
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Group/Cohort Intervention/treatment
endemic
Samples collected from areas endemic for zika. Subject specimens underwent testing with the study device and reference method.
 Other: ZIKV Detect™ 2.0 IgM Capture ELISA
De-identified archive specimens are tested by ELISA and compared to reference testing (RT-PCR and CDC MAC-ELISA)
non-endemic
Samples collected from areas non-endemic for zika. Subject specimens underwent testing with the study device and reference method.
 Other: ZIKV Detect™ 2.0 IgM Capture ELISA
De-identified archive specimens are tested by ELISA and compared to reference testing (RT-PCR and CDC MAC-ELISA)


Outcome Measures
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Primary Outcome Measures :
  1. Positive Percent Agreement and Negative Percent Agreement [ Time Frame: From symptom onset to 12 weeks after symptom onset. ]
    The positive percent agreement (PPA) and negative percent agreement (NPA) of the ZIKV Detect™ 2.0 IgM Capture ELISA versus the reference test.


Secondary Outcome Measures :
  1. Duration of Positive Percent Agreement [ Time Frame: From symptom onset to 12 weeks after symptom onset. ]
    The time period relative to onset of symptoms that a positive result can be identified and the time period after onset of symptoms that the positive percent agreement is maximized and the longest elapsed time after symptom onset that positive test results are observed.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Human males and females of varying ages and geographical locations where Zika virus is endemic and not endemic.
Criteria

Inclusion criteria:

  • Human males and females of varying ages and geographical locations where Zika virus is endemic and not endemic.
  • Retrospective (archived) and prospective human serum samples. Archived samples will fall under the category of "leftover" specimens as described by FDA guidance.

Exclusion criteria:

• Samples that are not de-identified.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03776903


Locations
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United States, Washington
InBios International
Seattle, Washington, United States, 98109
Sponsors and Collaborators
InBios International, Inc.
Fast-Track Drugs & Biologics, LLC
Biomedical Advanced Research and Development Authority
Investigators
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Study Director: Frances Chu, PhD InBios International
More Information
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Responsible Party: InBios International, Inc.
ClinicalTrials.gov Identifier: NCT03776903    
Other Study ID Numbers: ZIKV-2016-01
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Zika Virus Infection
Virus Diseases
Arbovirus Infections
 Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections